Hansen, Marit

Abstract [en]

Objectives Mycoplasma genitalium (MG) is a frequent etiology of urethritis and cervicitis, which can result in severe reproductive complications. Resistance in MG to first-line (azithromycin) and second-line (moxifloxacin) treatment has rapidly increased. Our aims were to examine the sensitivity and specificity of the new CE/IVD APTIMA MG assay (Hologic) and a research-use-only (RUO) APTIMA MG assay; and the prevalence of MG, C. trachomatis and N. gonorrhoeae; in Denmark, Norway and Sweden in 2016.

Methods From February 2016 to February 2017, urogenital specimens and extra-genital specimens (only in Denmark) from consecutive attendees at three STD clinics in Denmark, Norway and Sweden, were tested with the new CE/IVD APTIMA MG assay, RUO APTIMA MG assay, APTIMA CT/NG assay, and an in house TaqMan real-time mgpB qPCR. For analytical evaluation, genome-sequenced MG and other mycoplasma species in different concentration were tested.

Results In total, 5269 evaluable patients were included. The rate of MG infected patients was 7.2% (4.9-9.8% in the different countries). The sensitivity of the CE/IVD APTIMA MG assay, RUO APTIMA MG assay and mgpB qPCR ranged between 99.1-100%, 99.1-100%, and 73.2-81.6%, respectively, in the countries. The specificity of the CE/IVD APTIMA MG assay, RUO APTIMA MG assay and mgpB qPCR ranged between 99.6-99.96%, 100%, and 99.7-100%, respectively.

Conclusions Both the APTIMA MG assays had a superior sensitivity compared to the mgpB qPCR. The prevalence of MG was high and increased testing using validated and quality assured molecular tests for MG is crucial.